BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP

    MDR report key: 1791442 · Received August 6, 2010

    Report

    Report Number
    1644408-2010-00430
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 13, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    T-HANDLE INSTRUMENT BROKE AT END OF TIGHTENING IMPLANT DOWN.

    Description of Event or Problem · 2

    T-HANDLE INSTRUMENT BROKE AT END OF TIGHTENING IMPLANT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP CEMENT PLUG, INSERTER TEKNIMED LXH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1
    2